Trials / Completed
CompletedNCT02982746
Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Göteborg University · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
At all of the follow-ups, including the worst period (between four and ten weeks), the intervention group reported higher scores than the control group, suggesting in this RCT that adopting the person-centred-care concept was a promising way to improve function and wellbeing in patients with HNC.
Detailed description
Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its treatment may affect general domains of health-related quality of life (HRQoL) and provoke a variety of adverse symptoms and side effects, both during and after treatment. The objective of this study was to compare a person-centred care intervention in terms of HRQoL, disease-specific symptoms or problems, with traditional care as a control group for patients with HNC. Methods: The intervention and control groups comprised 54 and 42 patients, respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of treatment. The questionnaires' scores were compared between groups by using independent samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous variables. For categorical data, Fisher's exact test was used. Longitudinal data were analysed using repeated measures in covariance pattern models. Results: At baseline, the intervention and control groups were comparable in terms of medical and sociodemographic variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all the follow-up points, even during the worst period for the patients, the person-centred-care group consistently reported higher scores than the control group. The differences were numerically but not always statistically significant. When using repeated measures in covariance pattern models, statistically significant results were found for HNC-specific problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | gPCC (Gothenburg Person Centred Care) |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2016-12-05
- Last updated
- 2016-12-20
Source: ClinicalTrials.gov record NCT02982746. Inclusion in this directory is not an endorsement.